- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07927283
Fulvic Acid Supplementation and Metabolic Syndrome
Evaluation of Fulvic Acid Supplementation for the Attenuation of Symptoms Associated With Metabolic Syndrome
Fulvic acid is a naturally occurring compound derived from the decomposition of organic matter in soil over long periods. Fulvic acid complexes, such as MLG-50 (MLG-50® Mineral Logic, Kalamazoo, Michigan), offer a highly concentrated, water-soluble form of fulvic acid that contains over 70 trace minerals and elements. Our preclinical studies have found that a soil derived organic mineral complex rich in fulvic acid prevented the high fat diet induced hyperglycemia, endothelial dysfunction, liver injury, endotoxemia, and gut dysbiosis induced by high-fat feeding in rats. We propose to examine the efficacy of fulvic acid (both 50 mg and 100 mg daily for 12 weeks) in the mitigation of symptoms related to metabolic syndrome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical trials examining the efficacy of fulvic acid on health parameters are scarce. However, shilajit, a natural substance rich in fulvic acid, was shown to reduce triglycerides, cholesterol, and increase HDL cholesterol as well as antioxidant status in healthy college students (n=30) after 45 days of supplementation (2 g daily). However, this quasi-experimental trial did not randomize participants into experimental groups, and causality cannot be evaluated. A 2018 review of the peer-reviewed literature on the therapeutic potential of fulvic acid concluded that although the available research is minimal, there was 'substantial evidence' to pursue fulvic acid research for improving biomarkers linked to chronic inflammatory diseases.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carol Johnston, PhD
- Phone Number: 6024963463
- Email: carol.johnston@asu.edu
Study Contact Backup
- Name: Karen Sweazea, PhD
- Phone Number: 4809656025
- Email: karen.sweazea@asu.edu
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- PBC 850 N 5th Street
-
Contact:
- Carol Johnston, PhD
- Phone Number: 6024962539
- Email: carol.johnston@asu.edu
-
Contact:
- Karen Sweazea, PhD
- Phone Number: 4809656025
- Email: karen.sweazea@asu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- metabolic syndrome or prediabetes
Exclusion Criteria:
- pregnant or nursing
- multiple medications to treat obesity, heart disease, thyroid conditions, cancer
- smokers
- competing athletes
- vegetarians
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fulvic acid 50
50 mg |
50 mg 100 mg |
|
Experimental: Fulvic acid 100
100 mg |
50 mg 100 mg |
|
Placebo Comparator: Placebo
cornstarch |
cornstarch |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
girth
Time Frame: from enrollment to 6 week and to 12 week
|
waist circumference in cm |
from enrollment to 6 week and to 12 week
|
|
hypertension
Time Frame: from enrollment to 6 week and to 12 week
|
diastolic and systolic blood pressure |
from enrollment to 6 week and to 12 week
|
|
hyperglycemia
Time Frame: from enrollment to 6 week and to 12 week
|
fasting blood glucose |
from enrollment to 6 week and to 12 week
|
|
hypertriglyceridemia
Time Frame: from enrollment to 6 week and to 12 week
|
fasting blood triglycerides |
from enrollment to 6 week and to 12 week
|
|
cholesterol
Time Frame: from enrollment to 6 week and to 12 week
|
fasting blood HDL cholesterol |
from enrollment to 6 week and to 12 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00024356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
There is no IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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